FDA Halts Use of Most Monoclonal Antibodies for COVID Treatment
— Bamlanivimab/etesevimab, REGEN-COV not expected to work against Omicron
The monoclonal antibody combinations bamlanivimab/etesevimab and casirivimab/imdevimab (REGEN-COV) should only be used for COVID-19 patients exposed to variants other than Omicron, the FDA said on Monday.
The agency revised the emergency use authorization (EUA) for the two antibody cocktails for use “only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the statement. (See link for article)
- FDA cited “markedly reduced activity against the Omicron variant” as the reason for this revision.
- CDC data indicate that over 99% of U.S. COVID cases are from Omicron.
- The FDA action avoids exposing patients to side effects such as injection site reactions or allergic reactions. It is ironic the FDA isn’t concerned at all about COVID injection side-effects and deaths.
The FDA used the results of laboratory experiments in its sudden and unexpected decision to revoke EUAs for certain monoclonal antibody treatments for COVID-19, stating that data showed the treatments were ineffective against the Omicron variant.
The FDA; however, has been accused of being inconsistent with EUA COVID treatments since they authorized Merck’s antiviral pill in spite of clinical data demonstrating disappointing results. Remdesivir also has been conditionally recommended against use by the WHO due to lack of efficacy yet remains authorized by the FDA. The COVID injections also have far less efficacy against Omicron yet are still being used.
Similarly to the COVID injections wanning for variants, now one of mainstream medicine’s preferred COVID treatments also doesn’t work. Dr. Ruby explains that in her practice those getting COVID again are those who have either been treated with monoclonal antibodies or have gotten the COVID injections. She also states that getting the antibodies is like renting an army for the day. That they come in, provoke the immune system to fight, and then quickly disappear – unlike natural immunity which continues to work on your behalf. This treatment is also experimental, and much remains unknown.
Another important issue to point out is that PCR testing can not distinguish what variant you have.
Meanwhile, the censorship on doctors and effective COVID treatments continues under our corrupt public health ‘authorities’ who own patents on the pathogen, the tests, the treatments, and the “vaccines.” Hospitals have become modern-day “killing fields,” only utilizing the ineffective and dangerous treatments approved by corrupt authorities who care more about governmental incentive money than they do about patients.
- Fauci made the unusual move of announcing at a press conference from the White House in April, 2020 that the anti-viral Remdesivir for COVID diminishes time to recovery. He doesn’t discuss mortality at all.
- NIAID (where Fauci works) actually paid for the NIH study he alludes to. Being fully aware of the study he also knew that midway through it the primary end-point was changed from mortality to time to recovery. This was obviously done because researchers saw that remdesivir had no significant impact on mortality. Changing endpoints midway in a study should raise a lot of red-flags.
- Meanwhile, using evidence based on much larger studies, the WHO did not recommend remdesivir as they stated that there is no evidence that it improves survival or any other metric in patients.
- ‘Slight of hand’ statistical trickery such as:
- changing study end points
- using non-infection efficacy numbers
- and omitting absolute risk are continually being used to mislead the public into believing the accepted narrative that HCQ and Ivermectin are ineffective and/or dangerous, but that the COVID-19 injections are safe and effective.
- Remdesivir is manufactured by Gilead Sciences, a California-based company which has been accused of bioterrorism.
- The video then explains how at least 7 members of the COVID-19 treatment panel have financial ties to Gilead Sciences.